Phentermine Hydrochloride

Product NDC: 50436-6744
11-digit product format: 504366744
Labeler code: 50436
Product ID: 50436-6744_60ddd1bf-6ff5-442c-9fe8-417ebff5265a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA040555
Marketing category: ANDA
Marketing start: 2005-04-15
Marketing end: 0000-00-00
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 38 mg/1
Pharmacologic classes: Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-6744		I	Inactivated by FDA	2026-08-07
excluded package	package	50436-6744	50436-6744-1	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-6744	50436-6744-2	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-6744	50436-6744-3	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-6744	50436-6744-4	I	Inactivated by FDA	2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 75 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-6744-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-6744-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-6744-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-6744-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-6744-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-6744-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-6744-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-6744-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-6744-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-6744-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-6744-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-6744-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-6744-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-6744-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-6744-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-6744-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-6744-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-6744-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-6744-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-6744-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-6744-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-6744-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-6744-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-6744-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-6744-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-6744-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-6744-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-6744-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-6744-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-6744-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-6744-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-6744-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-6744-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-6744-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-6744-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-6744-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-6744-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-6744-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-6744-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-6744-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-6744-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-6744-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-6744-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-6744-4	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-6744-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-6744-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-6744-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-6744-4	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040555-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL			2005-04-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040555-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040555-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040555-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040555-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040555-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040555-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040555-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040555-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040555-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040555-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040555-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040555-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040555-001	AA	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040555-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3d272a3f-17c0-421d-bc43-3cbdb719258d	Product name	1	20250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1ab	Product name	2	20230717
ebeae3eb-385d-62da-8827-5ffa80b14e90	Product name	2	20170810
1d682039-1122-1cb7-f3f4-c0a028b98748	Product name	4	20170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56	Product name	3	20161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50436-6744-1	2023-01-30	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-2	2023-01-30	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-3	2023-01-30	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-4	2023-01-30	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-1	2021-08-06	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-2	2021-08-06	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-3	2021-08-06	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-4	2021-08-06	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-1	2021-01-29	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-2	2021-01-29	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-3	2021-01-29	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959
50436-6744-4	2021-01-29	These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets, USP . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-6744-1	Phentermine Hydrochloride	14 in 1 BOTTLE	TABLET	14	10
50436-6744-2	Phentermine Hydrochloride	7 in 1 BOTTLE	TABLET	7	10
50436-6744-3	Phentermine Hydrochloride	30 in 1 BOTTLE	TABLET	30	10
50436-6744-4	Phentermine Hydrochloride	28 in 1 BOTTLE	TABLET	28	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-6744-1	EA - Each	50436-6744	55ad06ba-cbd5-445d-97ed-b17fc520ea8e	1	2015-10-02
50436-6744-2	EA - Each	50436-6744	5ce36a0b-1e72-4b4e-b8a0-336cbb3bae62	1	2015-10-02
50436-6744-3	EA - Each	50436-6744	9dbbaf08-bd40-4fe4-94ef-af6418badbc0	1	2015-10-02
50436-6744-4	EA - Each	50436-6744	0ed2e0a8-4575-4fbd-b742-905ae1fb0b10	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-6744	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	10	Legacy NDC, 4 package rows	20210808_ef061dd2-1b35-49bf-beda-8c9fe02e5f9f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K2I505OTV	PHENTERMINE HYDROCHLORIDE	1197-21-3	PHENTERMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	ef061dd2-1b35-49bf-beda-8c9fe02e5f9f	10
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	ef061dd2-1b35-49bf-beda-8c9fe02e5f9f	10
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	ef061dd2-1b35-49bf-beda-8c9fe02e5f9f	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-6744-1	50436674401	14 TABLET in 1 BOTTLE (50436-6744-1)	14 tablet	2021-08-05	0000-00-00	No	No	Current
50436-6744-2	50436674402	7 TABLET in 1 BOTTLE (50436-6744-2)	7 tablet	2021-08-05	0000-00-00	No	No	Current
50436-6744-3	50436674403	30 TABLET in 1 BOTTLE (50436-6744-3)	30 tablet	2021-08-05	0000-00-00	No	No	Current
50436-6744-4	50436674404	28 TABLET in 1 BOTTLE (50436-6744-4)	28 tablet	2021-08-05	0000-00-00	No	No	Current